MAUDE Adverse Event Report: EXACTECH, INC. LOGIC FEMORAL PS CEM RIGHT SZ 3.5; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-010-01-0335
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Discomfort (2330)
Date of Event	11/10/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the patient had an initial right tka on (b)(6) 2017.The patient was revised on (b)(6) 2023 due to the recall of the poly, however, when the surgeon tapped on the femur it showed signs of listening, so he revised the femur as well.There was no reported breakage of a device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
H3: pending investigation.D10: (b)(6): 02-012-35-3513 - logic tibia ps mod insrt sz 3.5 13mm.(b)(6): 204-70-00 - tibial stem ext.Screw.(b)(6): 204-34-02 - fluted stem extension 25l x 14 mm.(b)(6): 02-012-45-3525 - lgc tibial fit tray cem sz 3.5f / 2.5t.(b)(6): 200-02-32 - three peg patella 32mm.
Additional Manufacturer Narrative
The reason for the revision reported may be the result of femoral loosening or due to inclusion of the polyethylene in the packaging recall.Failure of the cement used to secure the femoral component to the femoral bone, may have lead to loosening at the cement-implant interface; however, this cannot be confirmed.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation.This follow-up report is being submitted to relay corrected information.The following sections were corrected: h6 clinical code.This follow-up report is being submitted to relay additional information.The following sections were updated: d4 catalog number and udi#.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: d1/d2a/d2b, d4, h4.The reason for the revision reported may be the result of femoral loosening or due to inclusion of the polyethylene in the packaging recall.Failure of the cement used to secure the femoral component to the femoral bone, may have lead to loosening at the cement-implant interface; however, this cannot be confirmed.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: LOGIC FEMORAL PS CEM RIGHT SZ 3.5
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18253684
• Report Number: 1038671-2023-02894
• Device Sequence Number: 5540950
• Product Code: JWH
• UDI-Device Identifier: 10885862001245
• UDI-Public: 10885862001245
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K093360
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/02/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/10/2021
• Device Catalogue Number: 02-010-01-0335
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2023
• Supplement Date Received by Manufacturer: 04/01/2025; 04/01/2025
• Initial Report FDA Received Date: 12/03/2023
• Supplement Report FDA Received Date: 04/01/2025; 04/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male